Drug-target interactions

Drug-Target interactions

Preclinical PK/PD data issued from animal studies, provide the basis for in silico modeling and simulation of the human PK/PD characteristics of the drug, leading to determination of the minimum anticipated biological effect level (MABEL) and the selection of the first human dose for clinical trials. However, the recent tragedy in the BIA 10-2474 study revealed some critical pitfalls in the design of “First-In-Human” (FIH) trials, and pushed the European Medicine Agency to initiate a concept paper to improve strategies to identify and reduce risks in FIH studies on healthy volunteers.

Therefore, the evaluation of PK/PD in these early phase clinical trials are of outstanding importance to understand whether a drug behaves in the human body as expected based on animal studies, and to optimize dosing regimens for subsequent efficacy and safety studies and later-stage clinical trials.

ABL develops flow cytometry based ligand binding assays, for instance receptor saturation assays, to quantitatively assess the binding of a therapeutic agent to its cellular target.

If you want to learn more about our customized assays, please contact us

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